Clinical Trials

Inclusion Criteria:

1. Pathologically confirmed pancreatic ductal adenocarcinoma

2. Treatment-naïve

3. Staged as resectable or borderline-resectable

4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e.,
chemotherapy, radiation therapy, or combination) and subsequent possible surgical
resection

5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

6. Age ≥ 18 years

7. Completed informed consent as determined per the IRB of record

Exclusion Criteria:

1. Pregnant as determined by a pregnancy test as per institutional guidelines for
individuals of child-bearing potential

2. Declining to use effective contraceptive methods during the study (for individuals of
child-producing potential)

3. Need for emergent surgery that would be delayed by participation

4. Bacterial, viral, or fungal infections requiring systemic therapy

5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney
failure, liver failure, systemic or local inflammatory or autoimmune diseases or other
conditions) that in the opinion of the investigator, physician of record and/or Sofie
could compromise patient safety and/or protocol objectives.

6. Known diagnosis of autoimmune disorders

7. Patients receiving any other investigational agent within the past 28 days

8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits
to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of
the [68Ga]FAPI-46 injection.

9. Known hypersensitivity to any excipients used in [68Ga]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.